MAUDE Adverse Event Report: TOSAMA D.O.O. CORA; UNSCENTED MENSTRUAL TAMPON

Model Number	02Tampons-303
Medical Device Problem Codes	Unraveled Material (1664); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Toxic Shock Syndrome (2108)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information from this event will be included in our complaint and mdr trend analysis.
Event or Problem Description
Mid-cycle, user inserted a new tampon.Within an hour after insertion the user began to feel extremely sick.Symptoms: extreme headache, dizziness, sharp abdominal pain, and body aches.User left work and removed tampon.Upon removal the tampon was unraveling and had a "hard dark plastic thing inside the cotton" which was discovered after picking the tampon apart.Within 10 minutes of removing tampon the user's abdominal pain subsided and by the end of the day all symptoms were gone.Because of covid, user consulted a healthcare provider via telemedicine and from the symptoms the healthcare provider determined that the user more than likely experienced tss.No injury or medical intervention needed was reported.

• Brand Name: CORA
• Common Device Name: UNSCENTED MENSTRUAL TAMPON
• Manufacturer (Section D): TOSAMA D.O.O.; saranoviceva cesta 35, vir; domzale, 1230 ; SI 1230
• MDR Report Key: 10371813
• Report Number: 3007740671-2020-00001
• Device Sequence Number: 3001107
• Product Code: HEB
• UDI-Device Identifier: 00850373007379
• UDI-Public: 00850373007379
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 02Tampons-303
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other